- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02493803
Impact of Dietary Advice on the Progression of Tooth Wear (DAI)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
A sample size of 60 patients will be recruited separately from an epidemiology study and written informed consent will be obtained. Patients presenting with moderate to severe tooth wear will be recruited. Those with a Basic Erosive Wear Examination (BEWE) cumulative score greater than or equal to 8 but with at least one score of 3 on the occlusal surfaces of the lower molars or the incisal edge of the upper central incisor. After randomisation, an impression will be taken of the upper and lower teeth using a silicone material. One group will receive one-to-one dietary advice (with dietary information sheets) as the intervention and the other group will not receive any intervention. The silicone impressions will be repeated 6 months later. Impressions will be cast in stone and the occlusal surfaces of the upper or lower molars and the buccal surface of the upper central and lateral incisors will be scanned to monitor tooth wear progression. The two scans of the involved teeth will be superimposed and the level of tooth wear over that time will be calculated.
The investigators aim to see if giving detailed dietary advice will result in less erosive tooth wear.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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London, Royaume-Uni, SE1 9RT
- Dental Institute, Guy's Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Severe tooth wear with a BEWE score of 3 on the occlusal surface of the first lower molars or incisal/buccal surface of the upper central incisor.
- This wear will be as a result of a high acid diet i.e. as at least two dietary acidic challenges a day.
- Adult 25-70 years old.
- Minimum of at least 10 occluding tooth pairs (i.e. at least 10 upper teeth which bite against 10 lower teeth) - including the opposing upper molars and lower incisors
- No anterior crowns/ bridges or implants opposing the lower molars or upper incisors
- Written consent to the study
Exclusion Criteria:
- Pregnancy or breast feeding
- Medical history likely to impact on attendance or mobility
- Presence of periodontal disease or caries on more than one tooth. BPE score of 2 or above.
- Unable to speak or understand English
- Saliva diagnoses (xerostomia- dry mouth)
- Orthodontic appliances
- Severe dentine hypersensitivity
- Restoration of the occlusal or incisal surfaces of upper anterior teeth and first molars.
- Have factors which could contraindicate their participation, such as any condition requiring the need for antibiotic premedication prior to a dental treatment, a condition requiring the need for long-term antibiotic use, blood thinning medications that prohibit the safe conduct of a dental cleaning or previous use of the weight loss medications.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Receive detailed dietary advice
Half of the participants will be randomly allocated to receive detailed dietary advice
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Detailed dietary advice and planning, complete with dietary information sheets which were developed with a dietitian and a dental psychologist
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Aucune intervention: Receive standard of care dietary advice
These patients will receive dietary advice which is the current standard of care
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Loss of tooth height
Délai: 6 months
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Models of the teeth taken at 6 month epochs will be scanned using a laser profilometer and superimposed to detect accurately the loss of tooth height that has occurred during the study
|
6 months
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RJ114/N306
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